Post-Marketing Safety Studies (PMSS)
Generate real-world evidence of safety to inform regulatory and market access decisions
The current health care landscape is dynamic, with evolving patient demographics, treatment preferences and emerging health challenges.
Regulatory bodies and payors are increasingly emphasizing the need for robust evidence of drug safety and effectiveness to ensure patient well-being and contribute to regulatory decision-making, market access negotiations and risk management strategies. As a result, companies are faced with an increasing number of assets requiring post-marketing safety studies (PMSS), and the need to respond efficiently is critical to ensure patient safety while maximizing patient access. Additionally, increasing guidance on pregnancy and lactation studies has contributed to the expansion of safety studies in this special population.
Move your products forward safely with studies that meet your needs for:
- Post-authorization safety studies (PASS)
- Post-marketing requirements (PMRs)
- Post-marketing commitments (PMCs)
- Expanded access programs (EAPs)
- Label expansion
- Pregnancy and lactation requirements
- Comparative effectiveness evidence
- Health technology assessment and payor submissions
Safety solutions for product access and longevity
Post-authorization safety studies
Assess the long-term safety profile of your intervention in large, real-world patient populations through PASS, PMRs and PMCs. These studies enable a comprehensive understanding of the safety and effectiveness of drugs and other interventions in real-world clinical practice, providing valuable insights into rare or long-term adverse events and ensuring ongoing monitoring and risk management.
Post-authorization efficacy studies
Explore the real-world effectiveness and impact of treatments in routine clinical practice through post-authorization efficacy studies (PAES). Evaluate treatment outcomes, comparative effectiveness and patient-related outcomes to inform evidence-based decision-making. These studies may be voluntary or imposed by regulatory authorities when efficacy concerns are identified, or clinical data are deemed insufficient when an asset is initially made available to patients. Intended to complement clinical efficacy data, PAES studies provide a more comprehensive view of how well the intervention works in a larger population.
Risk evaluation and mitigation strategies
Address all aspects of risk management for your product. Designed and implemented during the commercialization of an intervention, risk evaluation and mitigation strategies (REMS) ensure an acceptable risk-to-benefit ratio for products marketed in the U.S. that are known to exhibit specific risks. By continually monitoring regulatory, legislative and market dynamics involving product safety and benefit-risk balance, we provide you with comprehensive REMS strategies and plans to best meet your evidence needs.
Risk management plans
Monitor the safety of your product and ensure compliance with EU regulations with a comprehensive risk management plan (RMP). Proactive in nature, RMPs are designed to identify and manage potential risks associated with a new product, including monitoring safety outcomes and implementing risk assessment and minimization activities. Required as a condition of marketing authorization, RMPs must be updated throughout the entire life cycle of the product.
Safety surveillance and monitoring
Ensure continued success once your product is on the market. Continuous surveillance of drug safety in real-world usage enables you to identify adverse events that may not have manifested themselves in controlled trials. Through active surveillance, signal detection and analysis of adverse event reports, safety surveillance contributes to early detection and management of safety concerns.
Expanded access programs and label expansions
Remove barriers and increase global access to life-changing treatments that positively impact patients. Even with the recent trend toward accelerated approval, new treatments often do not make it to market fast enough to meet patient need. Our experienced access solutions team will partner with you to develop the right pathway — whether expanded access programs, open-label extension studies or rollover studies — for your product to reach its intended audience. Cut through the intricate and often confusing landscape of access programs and studies with clarity and guidance to confidently navigate this space.
Evidence of comparative effectiveness
Comparative effectiveness research compares different treatment options to determine which treatments are more effective in achieving desired outcomes, often evaluating the benefits and risks of various treatments in real-world settings to guide evidence-based decision-making. Demonstrate your product’s comparative effectiveness with existing products through:
Real-world data: Capture patient experiences and outcomes in routine clinical practice, including patient-reported and clinician-reported outcomes, to provide a comprehensive view of treatment effectiveness, side effects and patient-related outcomes.
Broader patient populations: Increase accuracy of your product effectiveness assessment in diverse patient populations found in safety studies, including greater representation within different demographics, comorbidities and health care settings.
Long-term outcomes: Evaluate the sustained effectiveness of treatments and assess their impact on patient well-being through the longitudinal treatment outcomes captured in safety studies.
Establishing stronger, more robust evidence of comparative effectiveness enables:
- Informed treatment decisions by health care providers who can identify treatments with better outcomes, safety profiles or specific benefits for certain populations, leading to personalized and optimized care.
- Optimization of evidence-based guidelines and policies by regulatory bodies, health care organizations and policymakers to guide informed decisions about treatment recommendations, formulary inclusion and reimbursement policies.
Benefits for regulatory and market access decision-making
Patient safety: Peri- and post-marketing safety studies prioritize patient safety by identifying potential risks and allowing for timely risk management interventions. These studies provide comprehensive safety data, enhancing regulatory decision-making and ensuring patient well-being.
Evidence-based decision-making: Robust safety and effectiveness data from these studies contribute to evidence-based decision-making by regulatory bodies, payors and health care providers. Accurate and reliable data inform regulatory approvals, market access negotiations and treatment guidelines for optimal patient care.
Market access and reimbursement: Safety and effectiveness data derived from real-world safety studies are vital for market access negotiations and reimbursement decisions. Demonstrating the real-world benefits and value of drugs through post-authorization studies strengthens the case for favorable pricing and reimbursement.
Scientific approach to patient safety
Optimizing post-marketing safety obligations requires a unified, holistic approach to understanding the research need and identifying the right study design that will generate the right data for the right stakeholders most efficiently.
Identify the best strategy for your product’s safety needs with our consultative approach and experience with regulators and regulatory bodies, combined with our integrated, comprehensive expertise across the product life cycle. We enable you to better understand and manage your product’s risk-benefit profile and create an evidence generation strategy to not only meet regulatory expectations but identify other opportunities to maximize your asset’s benefits relative to risk across your safety studies. By listening to your needs and truly understanding your specific safety goals, we customize a solution that works for you – whether through traditional safety studies or more innovative study designs like registry studies.
